Karen Boyd, ASQ CQA Safety is #1, in my opinion; part of overall FFF (Fit, Form, and Function).

John G. Caruso Hard to point out only one. Karen summed it up pretty good. I would add a robust quality control system for consistency.

Karen Boyd, ASQ CQA It is hard, John! Yes, thank you. We can't ensure safety or much else without a robust quality control system or QMS. :)

Jakob Nielsen Safety is a good point...But what about DQ For the injection moulding process and tooling ?

Karen Boyd, ASQ CQA FFF - tolerance control, capability, and repeatability...

Karen Boyd, ASQ CQA Process Validation of course!

Stuart Briefer What pain or problem does it solve today and will the same need require the device tomorrow? Safety, Quality and raw materials to produce are assumed.

John G. Caruso Stuart, Design Qualification refers to the protocols you put into place to ensure quality and consistency of all of the individual components you use in a device your manufacturing and bringing to market. You put these protocols in place with each and every supplier and you require proof of compliance.

John G. Caruso Process validation does sum it up, but seems too general since D.Q. requires a complete vertical path though suppliers of suppliers.

Jakob Nielsen Proces validation is a part of the validation stage, but comes in my openion after DQ...

Jakob Nielsen Normally when i do a DQ for a injection moulding part design i look at things as filling, gating, cooling, ejecting aso. and then when you have the mould completed you can start a validation of the process....

Karen Boyd, ASQ CQA So for qualifying your design (DQ) for injection molding process and tooling, what is most important to analyze? You would start at the specifications for the mold and correspondent tooling. You're designing, so do you have a drawing to identify the mold dimensions and materials / tools to process and/or instructions for the molding process? That would be necessary to ensure the process is completed appropriately. Of course, you would be validating that process to ensure the molding is performed to specification consistently and repeatably.

John G. Caruso Drawings for the tooling? I don't think that would be necessary because the tooling is made from your part drawings. I think it would be more important to have a clear inspection/quality process in place so you know what's coming out of the tooling is consistently acceptable.

John G. Caruso I'm sorry. I meant to write: I don't think that would be necessary because the tooling is made from your (CAD data) and part drawings.

Jakob Nielsen YOU use a URS (User requirement specification) to identify your specification for the mould and machine but you use a DQ to make a qualification of your part and mould design...